哥斯达黎加生物研究局Rolando Herrero小组的一项最新研究揭示了一剂HPV疫苗不劣于两剂的效果。该项研究成果发表在2025年12月3日出版的《新英格兰医学杂志》上。

背景:多剂量人乳头瘤病毒（HPV）疫苗接种是有效的，但该疫苗在全球范围内尚未得到充分利用。新出现的数据表明，单次剂量可能提供保护。单剂HPV疫苗是否能提供与两剂相似的保护还不确定。

方法:在这项试验中，课题组研究人员评估了一剂HPV疫苗是否优于两剂。12至16岁的女孩按1:1:1:1的比例随机分配，接受一剂或两剂二价HPV疫苗或一剂或两剂非价HPV疫苗。主要终点是新的HPV 16型或18型感染发生在12个月至60个月，并持续至少6个月。预先指定的非劣效性裕度为每100名受试者1.25例感染。研究人员还通过比较试验参与者中的HPV16或HPV18感染与参加非随机调查的女孩和妇女中的HPV16或HPV18感染来评估疫苗的有效性。

结果:共有20330名参与者被纳入并进行随机分组，3005名未接种疫苗的参与者被纳入调查。非劣效性分析表明，一剂疫苗在预防HPV16或HPV18感染方面的效果不低于两剂。一剂和两剂二价疫苗的感染率差异为每100名参与者0.13例感染（95%可信区间为0.45至0.15;非劣效性P<0.001），一剂和两剂非价疫苗的感染率差异为每100名参与者0.21例感染（95%可信区间为0.09至0.51;非劣效性P<0.001）。在四个试验组中，疫苗的有效性至少为97%。没有发现安全隐患。

研究结果表明，一剂二价或非价HPV疫苗均可预防HPV16或HPV18感染，效果不低于两剂。

附：英文原文

Title: Noninferiority of One HPV Vaccine Dose to Two Doses

Author: Aimée R. Kreimer, Carolina Porras, Danping Liu, Allan Hildesheim, Loretto J. Carvajal, Rebeca Ocampo, Byron Romero, Mitchell H. Gail, Bernal Cortes, Monica S. Sierra, Karla Coronado, Joshua Sampson, Carolina Coto, Casey L. Dagnall, Daniela Mora, Troy J. Kemp, Michael Zuniga, Ligia A. Pinto, Gloriana Barrientos, John Schussler, Yenory Estrada, Cristian Montero, Carlos Avila, Dave Ruggieri, Jean T. Cyr, Stephen Chanock, Douglas R. Lowy, John T. Schiller, Rolando Herrero

Issue&Volume: 2025-12-03

Abstract: BACKGROUND

Multidose human papillomavirus (HPV) vaccination is efficacious, yet the vaccine has been underused globally. Emerging data suggest that a single dose may provide protection. Whether a single dose of HPV vaccine would provide similar protection to two doses is uncertain.

METHODS

In this trial, we assessed whether one dose of an HPV vaccine was noninferior to two doses. Girls 12 to 16 years of age were randomly assigned, in a 1:1:1:1 ratio, to receive one or two doses of a bivalent HPV vaccine or one or two doses of a nonavalent HPV vaccine. The primary end point was new HPV type 16 or 18 infection occurring from month 12 to month 60 and persisting for at least 6 months. The prespecified noninferiority margin was 1.25 infections per 100 participants. We also assessed vaccine effectiveness by comparing HPV16 or HPV18 infection among the trial participants with that among girls and women enrolled in a nonrandomized survey.

RESULTS

A total of 20,330 participants were enrolled and underwent randomization, and 3005 unvaccinated participants were enrolled in the survey. The noninferiority analysis showed that one vaccine dose was noninferior to two doses in preventing HPV16 or HPV18 infection. The rate difference between one and two doses of the bivalent vaccine was 0.13 infections per 100 participants (95% confidence interval [CI], 0.45 to 0.15; P<0.001 for noninferiority), and the difference between one and two doses of the nonavalent vaccine was 0.21 infections per 100 participants (95% CI, 0.09 to 0.51; P<0.001 for noninferiority). The vaccine effectiveness was at least 97% in each of the four trial groups. No safety concerns were identified.

CONCLUSIONS

One dose of either a bivalent or nonavalent HPV vaccine provided protection against HPV16 or HPV18 infection and was not inferior to two doses.

DOI: NJ202512030000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2506765